Duns Number:008999906
Device Description: The Fluent inflation device kit and components are to be used to facilitate the use of gui The Fluent inflation device kit and components are to be used to facilitate the use of guidewires, catheters, balloons, and other interventional devices during angioplasty procedures. Model 8257 contains Fluent inflation device, stopcock, guidewire introducer, hemostasis valve, torque device and 25 cm extension tube.
Catalog Number
-
Brand Name
Fluent™ inflation device
Version/Model Number
8257
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MAV
Product Code Name
Syringe, Balloon Inflation
Public Device Record Key
946087c2-2fba-4718-bb54-e6bc91536a7d
Public Version Date
May 06, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 238 |
| U | Unclassified | 12 |